Intralipid 20%

Leaflet attached to the packaging: information for the user

Intralipid 20%

200 mg/ml, emulsion for infusion

Soiae oleum raffinatum

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor, pharmacist or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Intralipid 20% and what is it used for
• 2. Important information before using Intralipid 20%
• 3. How to use Intralipid 20%
• 4. Possible side effects
• 5. How to store Intralipid 20%
• 6. Contents of the packaging and other information

1. What is Intralipid 20% and what is it used for

Intralipid 20% is a fat emulsion for parenteral nutrition. The medicine contains purified soybean oil, which provides the body with fatty acids necessary for energy production. The medicine should be used as a component of parenteral nutrition in combination with appropriate amounts of carbohydrate solutions, proteins, electrolytes, vitamins, and trace elements.
The medicine is administered by intravenous infusion.
Indications for use:
Intralipid 20% is indicated for use as a source of energy and fatty acids in parenteral nutrition. It is also intended for use in patients with fatty acid deficiency, in whom it is not possible to maintain or restore a normal level of these acids after oral administration.

2. Important information before using Intralipid 20%

When not to use Intralipid 20%

Do not use the medicine:

• if the patient is allergic to egg protein, soy, or peanuts, to the active substance or to any of the other ingredients of this medicine (listed in section 6);
• if the patient is in acute shock (a set of symptoms caused by insufficient oxygenation of vital organs);
• if the patient has severe hyperlipemia (a significant increase in cholesterol levels in the blood);
• if the patient has severe liver failure;
• if the patient has been diagnosed with hemophagocytic syndrome (a rare, life-threatening hereditary disease characterized by high fever, liver and/or spleen enlargement, and a significant decrease in the number of all blood cells).

Warnings and precautions

Intralipid 20% should be used with caution if the patient has:

• disturbed fat metabolism;
• kidney failure;
• uncontrolled diabetes;
• pancreatitis;
• liver function disorders;
• hyperthyroidism (if hypertriglyceridemia occurs - a significantly elevated level of triglycerides in the blood);
• sepsis (a systemic inflammatory response to infection). During the use of Intralipid 20% in these patients, the doctor will order blood tests (triglyceride levels).

Intralipid 20% should be used with caution in newborns and premature infants with hyperbilirubinemia (a significantly increased level of bilirubin in the blood) and in cases where pulmonary hypertension is suspected.
During long-term administration of Intralipid 20% to newborns, especially premature infants, the doctor will order blood tests (platelet count, liver enzyme activity, and triglyceride levels).
This medicine can affect the results of some tests. The doctor should be informed about the use of this medicine before the test is performed.
Intralipid 20% may rarely cause allergic reactions. Allergic reactions have also been observed after administration of this medicine and consumption of peanuts.
When used in newborns and children under 2 years of age, the solution (in the bag and administration set) should be protected from light until the end of administration (see section 2).

Intralipid 20% and other medicines

Tell the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Inform the doctor if the patient is taking:

• insulin (a medicine used to treat diabetes);
• heparin or coumarin derivatives (medicines used to reduce blood clotting).

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult a doctor or pharmacist before using this medicine.
The doctor will decide whether to use this medicine in pregnant or breastfeeding women.

Driving and using machines

Not applicable.

3. How to use Intralipid 20%

This medicine is administered only by medical personnel. The medicine should not be used by itself.
In case of doubts, consult a doctor.
The dosage is determined by the doctor individually for each patient, depending on age, body weight, and health status. Medical personnel may monitor the patient's health status during treatment.
When used in newborns and children under 2 years of age, the solution (in the bag and administration set) should be protected from light until the end of administration (see section 2).

Using a higher dose of Intralipid 20% than recommended

It is unlikely that the patient will receive too much of this medicine, as it is administered by medical personnel.
In case of overdose, there is a risk of taking in too much fat. This symptom is called "fat overload syndrome". For more information, see section 4: Possible side effects. If the patient notices the above symptoms or thinks they have received a higher dose of Intralipid 20% than recommended, they should immediately inform their doctor or nurse.
Acute overdose can lead to acidosis (an accumulation of excess acidic substances in the blood or a decrease in the level of alkaline substances), especially if carbohydrates are not administered.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Uncommon side effects(more than 1 in 100 patients and less than 1 in 1,000 patients):

• headache;
• increased body temperature;
• tremors;
• chills;
• feeling of fatigue;
• abdominal pain;
• nausea;
• vomiting.

Rare side effects(less than 1 in 10,000 patients):

• allergic reaction (hypersensitivity), which manifests as skin rash, swelling (especially of the lips, face, eyelids, tongue, and throat), shortness of breath, or fainting. In this case, the doctor should be contacted immediately.
• increased or decreased blood pressure;
• transient increase in liver enzyme activity. The doctor will inform the patient about the occurrence of this side effect.
• abdominal pain;
• thrombocytopenia (decrease in platelet count, manifested by bruising, easy bruising, and hemorrhages);
• hemolysis (breakdown of red blood cells);
• reticulocytosis (increase in the number of immature red blood cells);
• priapism (prolonged, painful erection);
• urticaria (light red, itchy blisters on the skin);
• skin rash.

Intralipid 20% may cause an increase in body temperature and, less often, tremors, chills, and nausea or vomiting (occurring less frequently than in 1 in 100 patients).
After long-term treatment:

• thrombocytopenia has been observed in infants;
• with or without the use of Intralipid 20%, transient increases in liver enzyme activity have been observed.

Fat overload syndrome

Fat overload syndrome occurs when the body has a problem with fat metabolism due to the administration of an excessive amount of Intralipid 20%. It can also occur due to a sudden change in the patient's health status (e.g., kidney problems or infection). Possible symptoms include fever, increased fat levels in the blood, cells, and tissues, disorders of multiple organ function, and coma. All these symptoms usually disappear after the infusion is stopped.

Reporting side effects

If any side effects occur, including any not listed in this leaflet, the doctor, pharmacist, or nurse should be informed. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
tel.: +48 22 49 21 301
fax: +48 22 49 21 309
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects can help gather more information on the safety of the medicine.

5. How to store Intralipid 20%

The medicine should be stored out of sight and reach of children.
The doctor or pharmacist is responsible for ensuring proper storage, use, and disposal of Intralipid 20%.
Store at a temperature below 25°C. Do not freeze.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
When used in newborns and children under 2 years of age, the solution (in the bag and administration set) should be protected from light until the end of administration (see section 2).

6. Contents of the packaging and other information

What Intralipid 20% contains

• The active substance of the medicine is soybean oil. 1000 ml of the emulsion contains 200 g of purified soybean oil (Soiae oleum raffinatum).
• Other ingredients (excipients) are: purified egg phospholipids, anhydrous glycerol, sodium hydroxide, and water for injection.

Osmolality:
350 mOsm/kg water
pH:
about 8
Energy value:
8.4 MJ (2000 kcal)/1000 ml
Organic phosphate content:
15 mmol/1000 ml

What Intralipid 20% looks like and what the packaging contains

The medicine is a white, homogeneous emulsion.
Packaging of the medicine:
Bottle
Bottles made of type II glass with a butyl rubber stopper and an aluminum-plastic cap.
Pack sizes:
100 ml in 1 bottle
250 ml in 1 bottle
500 ml in 1 bottle
Bag
The packaging consists of an inner Biofine bag and an outer bag.
The inner Biofine bag is made of plastic material.
Between the inner and outer bags, there is an oxygen absorber and a bag wall damage indicator.
Pack sizes:
100 ml in 1 bag
250 ml in 1 bag
500 ml in 1 bag
Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Fresenius Kabi AB
S-751 74 Uppsala
Sweden

Manufacturer

Bottles
Fresenius Kabi Austria GmbH
Hafnerstrasse 36
A-8055 Graz
Austria
Fresenius Kabi AB
S-751 74 Uppsala
Sweden
Bags
Fresenius Kabi AB
S-751 74 Uppsala
Sweden
To obtain more detailed information, contact the representative of the marketing authorization holder:
Fresenius Kabi Polska Sp. z o.o.
Al. Jerozolimskie 134
02-305 Warsaw
tel.: +48 22 345 67 89
Date of last revision of the leaflet:16.07.2021

Information intended for healthcare professionals only:

Dosage and administration

The dose and rate of administration of Intralipid 20% should be based on the patient's ability to eliminate fat.
See: "Fat elimination".
Dosage
1 g of triglycerides corresponds to 5 ml of Intralipid 20%.
Adult patients
The recommended maximum dose is 3 g of triglycerides/kg body weight/day. With this upper limit in mind, Intralipid 20% can be used to cover up to 70% of the energy requirement, even in patients with significantly increased energy requirements.
The rate of infusion of Intralipid 20% should not exceed 500 ml in 5 hours.
Newborns and infants
The recommended dose for newborns and infants is 0.5 to 4.0 g of triglycerides/kg body weight/day. The infusion rate should not exceed 0.17 g of triglycerides/kg body weight/hour (4 g/day).
For premature infants and newborns with low birth weight, Intralipid 20% should be administered at an initial dose of 0.5 to 1.0 g/kg body weight/day, gradually increased by 0.5 to 1.0 g/kg body weight/day to a dose of 2 g/kg body weight/day in continuous infusion over 24 hours.
Further dose increase to 4 g/kg body weight/day is possible only under strict control of triglyceride levels in serum, liver enzyme activity, and oxygen saturation.

Fat elimination

Adult patients
It is necessary to closely monitor the patient's ability to eliminate fat, especially in the conditions listed in section 4.4 "Special warnings and precautions for use" in the Summary of Product Characteristics and in patients who have been administered Intralipid 20% for more than one week.
To do this, blood samples should be taken for testing 5-6 hours after the end of the fat emulsion infusion. Blood cells should be separated from serum by centrifugation. The infusion should not be continued if the serum is cloudy. The sensitivity of this method is not sufficient to detect hypertriglyceridemia. Therefore, it is recommended to measure triglyceride levels in serum in patients suspected of having impaired fat tolerance.
Newborns and infants
In newborns and infants, it is necessary to regularly monitor the ability to eliminate fat. The only reliable method is to measure triglyceride levels in serum.

Overdose

Fat overload syndrome
Disorders of Intralipid 20% elimination may lead to fat overload syndrome due to the administration of a higher dose of the medicine than recommended.
This syndrome may also occur during the use of recommended infusion rates in connection with a sudden change in the patient's clinical condition, e.g., kidney disorders or infection. Fat overload syndrome is characterized by hyperlipemia, fever, fat infiltration, and disorders of multiple organ function, as well as coma. All symptoms of fat overload usually disappear after the infusion of Intralipid 20% is stopped.
Acute overdose caused by the administration of a fat emulsion containing triglycerides may lead to the development of acidosis, especially if carbohydrates are not administered.

Preparation of the medicine for use

Do not use if the packaging is damaged.
Check the bag wall damage indicator (Oxalert) before removing the outer bag. If the indicator is black, the outer bag is damaged and the medicine should be destroyed.
The outer bag, oxygen absorber, and bag wall damage indicator should be removed after opening the outer bag.
In the case of using the medicine in Biofine bags, see also: "Instructions for preparing the Biofine bag for use".

Special warnings and precautions for use

Exposure of parenteral nutrition solutions to light, especially after the addition of trace elements and/or vitamins, may have undesirable effects on the clinical response in newborns due to the formation of peroxides and other degradation products. When used in newborns and children under 2 years of age, Intralipid 20% should be protected from light until the end of administration.

Incompatibilities

Additional substances should be mixed with the medicine under aseptic conditions. Do not add electrolyte solutions alone to Intralipid 20%. Only medicines, nutrient solutions, or electrolyte solutions with documented compatibility should be added. On request, information can be obtained about the compatibility of the medicine with other solutions and additives, as well as the storage periods of prepared mixtures.

Storage conditions

Store at a temperature below 25°C. Do not freeze.
Storage after addition of other nutrient substances
Mixing in a plastic bag (without phthalates): the components of the mixture prepared under aseptic and validated conditions should be used within 7 days of preparation. The bag with the nutrient mixture can be stored for no more than 6 days in the refrigerator at a temperature between 2 and 8°C, then the infusion should be performed within 24 hours.

Disposal of leftovers

Any unused medicine or waste should be disposed of in accordance with local regulations.

Special precautions for disposal and preparation of the medicinal product for use

When used in newborns and children under 2 years of age, protect from light until the end of administration. Exposure of Intralipid 20% to light, especially after the addition of trace elements and/or vitamins, leads to the formation of peroxides and other degradation products, which can be limited by protecting from light.

Instructions for preparing the Biofine bag for use (attached only to the Biofine bag)

• 1.

Check the bag wall damage indicator (Oxalert) Abefore removing the outer bag. If the indicator is black, it means the outer bag is damaged and the medicine should be destroyed.

• 2.

Remove the outer bag by tearing the weld at the top and pulling along the packaging. The bag wall damage indicator Aand oxygen absorber Bshould be removed.

• 3.

In case of introducing additional substances, tear off the marked arrow plug of the white administration port.
If no additional substances are introduced, proceed to point 5.

• 4.

Insert the needle and administer additional substances (with established compatibility) through the center of the injection site. Use syringes with needles with a diameter of 18 to 23 G and a maximum length of 40 mm.

• 5.

Use an infusion device without an air vent or close the air inlet in the case of a device with an air vent. Follow the instructions for the infusion device. Use an infusion device with a diameter specified in ISO standard 8536-4, 5,6 ± 0,1 mm.

• 6.

Remove the plug of the blue infusion port.

• 7.

Hold the base of the infusion port. Insert the spike of the infusion device into the infusion port and gently screw it in until it is fully inserted.

• 8.

Hang the bag using the prepared hanger and start the infusion.